FDA approves once-weekly dosing for Amgen’s Kyprolis in multiple myeloma treatment

The United States Food and Drug Administration (FDA) has granted approval for a new once-weekly dosing regimen of Amgen‘s Kyprolis (carfilzomib) in combination with dexamethasone for patients with relapsed or refractory multiple myeloma. This new regimen, known as the once-weekly Kd70, involves administering Kyprolis at a dose of 70 mg/m². The approval follows the results of the phase 3 A.R.R.O.W. trial, which demonstrated that this new dosing option provides superior progression-free survival (PFS) and overall response rates (ORR) compared to the previously approved twice-weekly dosing regimen of 27 mg/m².

FDA Approval and Trial Results

The new dosing option of Kyprolis, administered weekly at 70 mg/m² alongside dexamethasone, has shown significant improvements in treatment outcomes compared to the twice-weekly regimen. The A.R.R.O.W. trial results indicated that the once-weekly regimen not only improved PFS and ORR but also maintained a comparable safety profile to the more frequent dosing schedule. This development marks a significant advancement in the treatment of multiple myeloma, providing a more convenient option for patients while ensuring effective management of the disease.

Expert Commentary on the New Regimen

Dr. David S. Siegel, Chief of the Division of Multiple Myeloma at John Theurer Cancer Center at Hackensack University Medical Center, expressed his views on the approval. He highlighted the importance of offering treatment options that cater to the needs of individual patients, noting that despite significant progress in the past decade, multiple myeloma remains an incurable condition with recurring patterns of remission and relapse. Dr. Siegel emphasized that the new once-weekly regimen offers improved efficacy and convenience, potentially allowing patients more time outside the infusion center.

Amgen’s Perspective on the Approval

David M. Reese, Executive Vice President of Research and Development at Amgen, commented on the FDA’s decision. Reese praised the approval as a testament to Amgen’s commitment to advancing treatment options for multiple myeloma. He acknowledged the company’s dedication to generating evidence and innovating within the field, stating that the new dosing regimen of Kyprolis provides patients with a more convenient and effective treatment option.

Kyprolis: Mechanism and History

Kyprolis, which received its initial approval in 2012, functions as a proteasome inhibitor. By disrupting the proteasome’s ability to break down damaged or unnecessary proteins, Kyprolis leads to the accumulation of these proteins within cells. This mechanism is particularly effective against myeloma cells, which often have an excess of abnormal proteins, leading to cell death and, consequently, a reduction in cancerous cells.

Unapproved Dosing Regimen

It is important to note that the FDA has not approved Kyprolis for the twice-weekly dosing regimen of 27 mg/m² combined with dexamethasone alone. The new once-weekly dosing option represents a significant shift in the treatment landscape, offering a more manageable regimen without compromising effectiveness or safety.